[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]




                               before the

                         COMMITTEE ON OVERSIGHT
                         AND GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES


                             SECOND SESSION


                             JUNE 17, 2010


                           Serial No. 111-93


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                   EDOLPHUS TOWNS, New York, Chairman
PAUL E. KANJORSKI, Pennsylvania      DARRELL E. ISSA, California
CAROLYN B. MALONEY, New York         DAN BURTON, Indiana
ELIJAH E. CUMMINGS, Maryland         JOHN L. MICA, Florida
DENNIS J. KUCINICH, Ohio             JOHN J. DUNCAN, Jr., Tennessee
JOHN F. TIERNEY, Massachusetts       MICHAEL R. TURNER, Ohio
WM. LACY CLAY, Missouri              LYNN A. WESTMORELAND, Georgia
DIANE E. WATSON, California          PATRICK T. McHENRY, North Carolina
STEPHEN F. LYNCH, Massachusetts      BRIAN P. BILBRAY, California
JIM COOPER, Tennessee                JIM JORDAN, Ohio
GERALD E. CONNOLLY, Virginia         JEFF FLAKE, Arizona
MIKE QUIGLEY, Illinois               JEFF FORTENBERRY, Nebraska
MARCY KAPTUR, Ohio                   JASON CHAFFETZ, Utah
    Columbia                         BLAINE LUETKEMEYER, Missouri
PATRICK J. KENNEDY, Rhode Island     ANH ``JOSEPH'' CAO, Louisiana
DANNY K. DAVIS, Illinois             BILL SHUSTER, Pennsylvania
PAUL W. HODES, New Hampshire
JUDY CHU, California

                      Ron Stroman, Staff Director
                Michael McCarthy, Deputy Staff Director
                      Carla Hultberg, Chief Clerk
                  Larry Brady, Minority Staff Director

                            C O N T E N T S

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



                        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 
    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 review 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 
    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 




    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:]

    [GRAPHIC] [TIFF OMITTED] T2946.004
    [GRAPHIC] [TIFF OMITTED] T2946.005
    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 
    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 
    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 California'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.
    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 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 needle-exchange 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 


    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 
    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.



    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.
    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 baby-boomer 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.
    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 
    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 
    Chairman Towns. I thank the gentleman from Georgia for his 
    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.


    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 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, 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 
    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 3\1/2\ 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 $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 
    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.
    [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 2\1/2\ 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 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.
    [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.
    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 
    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?
    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 
    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 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 
    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 
    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.
    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 


    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 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 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 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 
    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 
    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 
    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 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 
    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 
    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.
    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 4\1/2\ 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 
    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 
    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 
    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 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 
    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.
    Mr. Clay. And I realize that this administration does quite 
a bit with interagency strategies. How has that worked in this 
    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. 
    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.
    Dr. Koh. Thank you, Mr. Chairman.
    Dr. Ward. Thank you very much.
    Chairman Towns. Pleasure.
    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 


                    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 chronic viral hepatitis. This condition is 
three to five times more frequent than HIV in the United 
States. Between 3\1/2\ 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 
    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 
    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.


    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 
    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.
    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 
    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 
    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 
    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 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 
    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.


    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 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 virus-
free, 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 
    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:]