<DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:97775.wais]
STALKING A FURTIVE KILLER: A REVIEW OF THE FEDERAL GOVERNMENT'S EFFORTS
TO COMBAT HEPATITIS C
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
DECEMBER 14, 2004
__________
Serial No. 108-275
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
TODD RUSSELL PLATTS, Pennsylvania JOHN F. TIERNEY, Massachusetts
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida DIANE E. WATSON, California
EDWARD L. SCHROCK, Virginia STEPHEN F. LYNCH, Massachusetts
JOHN J. DUNCAN, Jr., Tennessee CHRIS VAN HOLLEN, Maryland
NATHAN DEAL, Georgia LINDA T. SANCHEZ, California
CANDICE S. MILLER, Michigan C.A. ``DUTCH'' RUPPERSBERGER,
TIM MURPHY, Pennsylvania Maryland
MICHAEL R. TURNER, Ohio ELEANOR HOLMES NORTON, District of
JOHN R. CARTER, Texas Columbia
MARSHA BLACKBURN, Tennessee JIM COOPER, Tennessee
PATRICK J. TIBERI, Ohio BETTY McCOLLUM, Minnesota
KATHERINE HARRIS, Florida ------
MICHAEL C. BURGESS, Texas BERNARD SANDERS, Vermont
(Independent)
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
C O N T E N T S
----------
Page
Hearing held on December 14, 2004................................ 1
Statement of:
Khabbaz, Rima, M.D., Associate Director of Epidemiologic
Science, National Center for Infectious Diseases, Center
for Disease Control and Prevention, accompanied by Eric
Mast, M.D., Acting Director of the Division of Viral
Hepatitis; Jay Hoofnagle, M.D., Liver Disease Research
Branch, Division of Digestive Diseases and Nutrition,
National Institute of Diabetes and Digestive Kidney
Diseases, National Institutes of Health; and Lawrence
Deyton, MSPH, M.D., Chief Consultant, Public Health
Strategic Healthcare Group, Department of Veterans Affairs,
accompanied by Michael Rigsby, M.D, Director of the
National Program Office for HIV and hepatitis C, Veterans
Health Administration...................................... 15
Rudman, Michael, M.D., founder, Frederick County Hepatitis
Clinic, Inc.; Ann Jesse, founding executive director, HEP C
Connection; John Niemiec, first vice president, Fairfax
County Professional Fire Fighters and Paramedics; and Erika
Stein, Robinson Secondary School DECA student (father has
hepatitis C)............................................... 74
Letters, statements, etc., submitted for the record by:
Cummings, Hon. Elijah E., a Representative in Congress from
the State of Maryland, prepared statement of............... 120
Davis, Chairman Tom, a Representative in Congress from the
State of Virginia, prepared statement of................... 4
Deyton, Lawrence, MSPH, M.D., Chief Consultant, Public Health
Strategic Healthcare Group, Department of Veterans Affairs,
prepared statement of...................................... 43
Hoofnagle, Jay, M.D., Liver Disease Research Branch, Division
of Digestive Diseases and Nutrition, National Institute of
Diabetes and Digestive Kidney Diseases, National Institutes
of Health, prepared statement of........................... 29
Jackson Lee, Hon. Sheila, a Representative in Congress from
the State of Texas, prepared statement of.................. 128
Jesse, Ann, founding executive director, HEP C Connection,
prepared statement of...................................... 85
Khabbaz, Rima, M.D., Associate Director of Epidemiologic
Science, National Center for Infectious Diseases, Center
for Disease Control and Prevention, prepared statement of.. 18
Niemiec, John, first vice president, Fairfax County
Professional Fire Fighters and Paramedics, prepared
statement of............................................... 97
Ros-Lehtinen, Hon. Ileana, a Representative in Congress from
the State of Florida, prepared statement of................ 124
Rudman, Michael, M.D., founder, Frederick County Hepatitis
Clinic, Inc., prepared statement of........................ 77
Souder, Hon. Mark E., a Representative in Congress from the
State of Indiana, prepared statement of.................... 111
Stein, Erika, Robinson Secondary School DECA student (father
has hepatitis C), prepared statement of.................... 101
Waxman, Hon. Henry A., a Representative in Congress from the
State of California:
Letter dated October 7, 2004............................. 63
Prepared statement of.................................... 9
Wilson, Hon. Heather, a Representative in Congress from the
State of New Mexico, prepared statement of................. 125
STALKING A FURTIVE KILLER: A REVIEW OF THE FEDERAL GOVERNMENT'S EFFORTS
TO COMBAT HEPATITIS C
----------
TUESDAY, DECEMBER 14, 2004
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 2 p.m., in room
2154, Rayburn House Office Building, Hon. Tom Davis (chairman
of the committee) presiding.
Present: Representatives Tom Davis, Waxman, Towns and
Norton.
Staff present: David Marin, deputy staff director/
communications director; Robert White, press secretary; Drew
Crockett, deputy director of communications; Susie Schulte,
professional staff member; Teresa Austin, chief clerk; Sarah
Dorsie, deputy clerk; Corinne Zaccagnini, chief information
officer; Bill Womack, legislative director; Amy Westmoreland,
legislative assistant, Karen Lightfoot, minority communications
director/senior policy advisor; Sarah Despres, minority
counsel; Josh Sharfstein, minority professional staff member;
Earley Green, minority chief clerk; and Jean Gosa, minority
assistant clerk.
Chairman Tom Davis. With a quorum being present, the
Committee on Government Reform will come to order; and I want
to welcome everybody to today's oversight hearing on the
significant public health threat posed by hepatitis C.
Most people probably don't realize that hepatitis C is now
the most common blood-borne viral infection in the United
States, affecting nearly 4 million Americans. Hepatitis C is
also a leading cause of chronic liver disease, now the 10th
leading cause of death among adults in the United States.
In 1998, this committee held a hearing on the need to
improve the Nation's response to hepatitis C. At that hearing,
several specific points of action were recommended. Today, we
will examine what progress has been made in responding to the
hepatitis C epidemic. We also hope to identify areas for
improvement.
Hepatitis C was only identified 15 years ago, so we still
have a lot to learn about this disease. We have learned that
significant obstacles to fighting hepatitis C exists. There is
currently no vaccine to shield against hepatitis C virus. There
are vaccines against hepatitis A and B; however, the structure
of the hepatitis C virus has proved a difficult puzzle for
medical researchers to solve.
Today, we will hear from NIH whether it's reasonable to
expect availability of a hepatitis C vaccine in the near
future. Pharmaceutical treatments are available but only
successful about 50 percent of the time under ideal conditions.
They are also attended by side effects, sometimes so
devastating they often are not an option for many patients with
hepatitis C infection.
Second, infection with hepatitis C virus generally carries
no symptoms but gradually damages the liver over the course of
many years or even decades. It's discovered only after a
patient exhibits signs of serious liver disease, such as
cirrhosis or liver cancer. Since the virus lasts for such a
long period of time, it is possible for infected persons to
disassociate or even forget about long-ago instances of drug
use or other high-risk behavior. Thus, the individual doesn't
address their own illness, nor do they take steps to stem the
spread of the virus to others.
A final obstacle is that hepatitis C, while a serious
public health issue, remains relatively unknown to the general
public. Those affected often come from marginalized
populations, intravenous drug users and prisoners, for example,
lacking the political organization to effectively raise public
awareness about the disease.
Public health officials face the challenge of informing,
rather than panicking, the public about hepatitis C, a task
made even more difficult given our still-evolving knowledge
base. It seems to me that there is a misperception that
hepatitis C is a disease affecting, ``somebody else.'' However,
social strata provide no prophylaxis. This misperception
underscores the need to establish effective programs to educate
both health care providers and the public at large about the
dangers of hepatitis C and the high-risk activities that tend
to spread it.
This hearing sets the stage to review our Nation's response
to hepatitis C. Several questions we would like answered today
include: How well are hepatitis C prevention strategies
working? Are we screening enough people to identify persons at
risk for infection? What progress has been made in the last 5
years toward the quest for vaccine and developing better and
more effective treatments for hepatitis C? How well do the
Federal agencies share information among themselves and with
State health departments?
The current epidemic has challenged our public health
system's capabilities and provides us with a chance to evaluate
existing prevention, screening and treatment programs. The
Department of Veterans Affairs [VA], has an excellent hepatitis
C program and has taken the leading role in managing infection.
I am pleased we have a witness on our first panel to discuss
the proactive education, screening, treatment, counseling and
surveillance measures taken by the VA over the past few years.
We will take a look at how these programs are being implemented
and what lessons can be provided to the general public health
community.
In addition to the testimony from several medical and
public health experts, we will hear the personal story of a
teenage girl from Fairfax County whose father has hepatitis C.
Erika Stein has helped lead a marketing program at her high
school to raise awareness and get more Federal resources
allocated for prevention and research for the disease. We look
forward to her testimony.
The committee hopes to learn from the experiences of those
who feel the effects of hepatitis C infection every day. I
understand some of our witnesses this morning will express
concerns about the success of current hepatitis C prevention
efforts and identify areas where improvement is still needed. I
look forward to a constructive dialog on these concerns. I know
we all share the same goal at the end of the day, a public
health system that can adequately respond to the hepatitis C
epidemic.
We have an excellent roster of witnesses today. I want to
thank all of them for appearing before the committee. I look
forward to their testimony.
[The prepared statement of Chairman Tom Davis follows:]
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Chairman Tom Davis. I would now like to yield to Ms. Norton
for her opening statement and then go to Mr. Waxman.
Ms. Norton. Thank you very much, Mr. Chairman.
Chairman Davis, I think you are performing a public
service, an unusually important public service, with today's
hearing. Of course, every hearing is a service to the public.
But I must say the first question that came to me as I prepared
for this hearing is why is this disease such a mystery to me
and why is it, I believe, such a mystery to most of the people
in this country? And I couldn't help but wonder whether we were
simply sitting on a problem where you have a highly contagious
disease like this which has no vaccine and no cure. Where is
the public health campaign and public health outcry about this
disease? Why am I sitting here, a Member of Congress, probably
as ignorant about it as the average American? That is very
troubling.
You consider the consequences, the contagion, when you
don't know about a disease, that you can then pass on through
intravenous drug use, you really are creating a public health
menace, that alarms should be raised about it. People should be
put on notice. Today's hearing for me is an opportunity to
understand why and what we can do about it. Very dangerous
disease. Most of the people who have it don't have any
symptoms. Here you are passing along a terrible disease and
don't know you have it and nobody is telling the public about
it.
Here we are sitting in the most advanced country in the
world when it comes to health matters, except when it comes to
making, of course, health care available to everybody. Why is
it that we aren't doing more about this disease?
Consider some of the consequences. This is one of the
diseases that leads to terrible liver disease, and people who
have liver disease need transplants. And about the most
expensive way to deal with the disease is to take an organ out
and put another one in. Yet there was a fivefold increase in
liver transplants in the 1990's.
I wonder whether it is the nature of the disease and the
people who have the disease that account for why we know so
little about it and have done so little about the disease. Do
we need a Ryan White to get the country's understanding, to get
CDC's attention? Because that is what it took, frankly, with
the AIDS crisis. If so, shame on us.
The fact that those who get this disease often are people
who use drugs, people who are in prison, I should say nothing
about the attention we pay to the disease. Unless there is
another explanation, I'm going to have to start with a
presumption that it's who gets the disease is responsible for
why we haven't done more, about why we haven't done more about
this disease.
Mr. Chairman, you are doing a great deal about it by having
this hearing today that may start us on the way to truly
raising the consciousness of the American people about
hepatitis C.
Chairman Tom Davis. Thank you very much.
I now recognize the ranking member, Mr. Waxman.
Mr. Waxman. Thank you, Chairman Davis, for calling this
hearing today on an important but often overlooked problem.
Inside the human body, the hepatitis C virus acts with
unusual stealth. Infected individuals may feel fine for years
and even decades and then, without warning, hepatitis C can
awaken and cause irreversible cirrhosis, liver failure and
death.
The stealth of the hepatitis C virus also has been evident
in the body politic. Over the past 2 decades, our government
has missed opportunities to take action to combat hepatitis C
and to alert the public to a growing threat. Now we find
ourselves facing a chronic blood-borne infection that affects 3
million Americans and kills 8,000 each year. We must first ask
what went wrong, and then we must be clear about the
opportunities we are missing even today to defeat hepatitis C.
By 1981, it was known that hundreds of thousands of
patients were contracting chronic hepatitis C from blood
transfusions. Even through the specific virus causing hepatitis
had yet to be identified and there was no specific screening
test, blood banks could have taken action to protect the
public, because, at the time, research showed that by screening
blood for evidence of liver disease in the donor thousands of
cases of transfusion-associated hepatitis could be prevented.
Such screening, however, was not required by the Food and Drug
Administration, and it was not adopted widely by blood banks
until 1987.
Two years later, in 1989, the hepatitis C virus was
discovered at a specific screening test. Blood banks and
hospitals could have looked back and identified people who had
been transfused with infected blood, but FDA decided against
requiring such a review.
The issue was revisited in the mid-1990's. Under the
leadership of HHS Secretary Donna Shalala, the Food and Drug
Administration oversaw notification of Americans transfused
with tainted blood after 1992. In 1999, FDA proposed extending
the notification back to individuals transfused prior to 1992,
but the current administration has resisted finalizing this
potentially life-saving rule.
There is a moral issue here. The government has neither
required notification of people who did receive tainted blood
nor conducted a broad public education campaign informing
anyone about who needs to get tested. The result is that many
people have no idea of the risks they face.
In 2000, Surgeon General David Satcher sought to write a
letter to every American's home about the threat of hepatitis
C. His effort was never funded.
In 2001, a national hepatitis C strategy was developed.
While CDC has begun to pursue important parts of this strategy,
many of its elements have yet to be fully funded and
implemented. As a consequence, millions of Americans at risk
remain unaware of the problem. Many who can benefit from
treatment never get it. And even today many infections that can
be prevented are not.
According to the Centers for Disease Control, 60 percent of
the new hepatitis C infections are transmitted by intravenous
drug use. Yet, across our country, many thousands of people who
want to get into drug treatment programs, programs that are
proven to work, can find no space available to them.
Scientific evidence also demonstrates that even those who
continue to use drugs can be kept safe from hepatitis C. Two
years ago, a consensus panel on hepatitis C convened by the
National Institutes of Health recommended, ``providing access
to sterile syringes through needle exchange, physician
prescription and pharmacy sales.'' The panel advised that
physicians and pharmacists should be educated to recognize that
providing intravenous drug users with access to sterile
syringes and education and safe infection practices may be
lifesaving. Yet, since then, not much progress in this area has
been made.
This is an area where right-wing ideology conflicts with
sound public health practices. Everyone wants to stop illegal
drug use, but because we know that some addicts will continue
to use drugs, it is essential to support needle exchange and
other life-saving measures. Those who oppose needle exchanges
are like those who oppose comprehensive sex education for
teenagers, which also has proven to be effective. Public health
policy needs to recognize reality and be based on facts and
science.
The infections that we fail to prevent today may not create
problems for tomorrow, but, as the years and decades pass, our
society will suffer the economic social burden of hepatitis C
infections that were entirely preventable. This is a terrible
legacy to our children. It's a terrible tragedy for those
involved.
I hope this hearing will shed light on the dangers of the
hepatitis C virus. We must work together to generate momentum
for legislation to address hepatitis C and to expand access
through drug treatment.
I thank the witnesses who are going to be here today and am
looking forward to their testimony.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Hon. Henry A. Waxman follows:]
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Chairman Tom Davis. Mr. Towns, any opening statement?
Mr. Towns. Thank you very much. I want to thank you, Mr.
Chairman, for holding this hearing.
Beginning in 1995, Representative Chris Shays of
Connecticut and I held a series of hearings on blood-borne
illnesses and hepatitis C. Our concerns for the safety of the
blood supply and the possible transmission of disease through
transfusion led us to ask hard questions about the Federal
policy.
During those hearings, we heard the moving testimony of the
Honorable Joe Moakley, former Chair of the Rules Committee,
from Massachusetts, who had contracted hepatitis C through a
blood transfusion. Unfortunately, he died from the disease
within a few years of those hearings. His death showed that
hepatitis C can happen to anyone. It made me aware of the fact
that education and prevention could not be solid components of
the Federal public strategy.
As a result of those hearings, the Centers for Disease
Control and Prevention agreed to engage in the first-ever
public education campaign on hepatitis C, which included a
requirement that the CDC take the unprecedented step of
notifying those people who may have been infected through blood
transfusions. Some public health officials are warning us that
the number of deaths from this disease will triple in the next
decade, from the estimate of 8,000 to 10,000 deaths per year to
an incredible 24,000 to 30,000 deaths per year. Because the
disease can be dormant for several years and only 30 percent of
those who are infected have any symptoms of the disease, these
estimates may be an understatement. But I'm hopeful we will not
see such an explosion before we take action.
That is why I join with my colleague, Heather Wilson, to
introduce H.R. 3539, the Hepatitis C Epidemic Control and
Prevention Act. This bipartisan bill will direct the Secretary
of Health and Human Services to establish, promote and support
a comprehensive prevention, research and medical management
referral program. For persons suffering from the hepatitis C
virus, if passed, this bill will represent the first Federal
effort to provide a strategic approach to combat this disease
by requiring the development and implementation of a plan for
public education, early detection, testing and counseling of
patients. Mr. Chairman, I know that you are a supporter of this
bill, and I want to thank you so much for that.
In March 2004, the U.S. Preventive Services Task Force, a
panel called together by an agency of the Department of Health
and Human Services, published recommendations which advised
against hepatitis C screening in people who are not in current
high-risk categories for the disease. The published
recommendations appear to indicate neutrality on whether adults
who are high risk should be screened. These recommendations
directly contradicted recommendations of the NIH and the
current accepted practice in the medical community. Mr.
Chairman, may I suggest that we have a hearing on the apparent
contradiction within the Federal Government on the issue of
hepatitis C screening.
On that note, let me thank you again for holding this
hearing; and I would like to thank the witnesses as well for
being here and to say to you that, with you, I hope we can make
certain that there is a serious and strategic Federal response
to hepatitis C. Mr. Chairman, we need to stay on this issue.
This is a very serious problem.
Chairman Tom Davis. Thank you very much for your leadership
on this as well, Mr. Towns; and I'm proud to be a co-sponsor of
your bill.
We are going to move to our first panel of witnesses who
will discuss efforts being taken at the Federal level to manage
the hepatitis C epidemic. They will also describe their efforts
to coordinate, educate, screen, treat, counsel and survey
measures.
We have Dr. Rima Khabbaz, the Associate Director of
Epidemiologic Science for the National Center for Infectious
Diseases. She'll be providing testimony on behalf of the CDC.
Dr. Eric Mast, the Acting Director of the Division of Viral
Hepatitis at CDC, accompanies Dr. Khabbaz and is available to
answer questions. So when we swear in witnesses we will have
both of them sworn in.
Dr. Jay Hoofnagle of the Liver Disease Research Branch at
NIH will provide testimony regarding research efforts in search
of a vaccine and more effective treatment options; and Dr.
Lawrence Deyton, the Chief Consultant of the Public Health
Strategic Healthcare Group at the Department of Veterans
Affairs, will discuss the VA's excellent hepatitis C program.
He's accompanied by Dr. Michael Rigsby, who is the Director of
the National Program Office for HIV and Hepatitis C at the
Veterans Health Administration. Dr. Rigsby will also be
available to answer questions posed by Members, so he'll be
sworn as well.
Would you please rise with me and raise your right hands.
[Witnesses sworn.]
Chairman Tom Davis. It's our policy that we swear you in
before you testify.
Dr. Khabbaz, I think I'll start with you--we will move
straight on down the line--and I thank you for your efforts in
this area and thank you for being with us today. We try to keep
our 5-minute presentation. Your entire testimony is in the
record. So thank you.
STATEMENTS OF RIMA KHABBAZ, M.D., ASSOCIATE DIRECTOR OF
EPIDEMIOLOGIC SCIENCE, NATIONAL CENTER FOR INFECTIOUS DISEASES,
CENTER FOR DISEASE CONTROL AND PREVENTION, ACCOMPANIED BY ERIC
MAST, M.D., ACTING DIRECTOR OF THE DIVISION OF VIRAL HEPATITIS;
JAY HOOFNAGLE, M.D., LIVER DISEASE RESEARCH BRANCH, DIVISION OF
DIGESTIVE DISEASES AND NUTRITION, NATIONAL INSTITUTE OF
DIABETES AND DIGESTIVE KIDNEY DISEASES, NATIONAL INSTITUTES OF
HEALTH; AND LAWRENCE DEYTON, MSPH, M.D., CHIEF CONSULTANT,
PUBLIC HEALTH STRATEGIC HEALTHCARE GROUP, DEPARTMENT OF
VETERANS AFFAIRS, ACCOMPANIED BY MICHAEL RIGSBY, M.D, DIRECTOR
OF THE NATIONAL PROGRAM OFFICE FOR HIV AND HEPATITIS C,
VETERANS HEALTH ADMINISTRATION
Dr. Khabbaz. Good afternoon, Mr. Chairman and members of
the committee. I am Dr. Rima Khabbaz, Associate Director for
Epidemiologic Science at the National Center for Infectious
Diseases at the CDC; and I'm accompanied today by Dr. Eric
Mast, the Acting Director of the Division of Viral Hepatitis.
We are pleased to be here, and we thank you for the opportunity
to describe the activities that CDC has undertaken with our
partners to implement the National Hepatitis C Prevention
Strategy, which this committee was instrumental in initiating
in 1999.
Hepatitis C virus [HCV], is indeed a very serious concern,
as it is today the most common cause of chronic liver disease
in the United States. It is the most common chronic blood-borne
infection. About 4 million Americans have already been
infected, and approximately 3 million are chronically infected,
and about 30,000 Americans become newly infected each year.
Unlike hepatitis A and B, there is no vaccine to prevent
infection with HCV. Because the consequences of chronic liver
disease from HCV may not become apparent for 10 to 20 years,
many infected persons are not aware of their infection.
The two major objectives of the National Hepatitis C
Prevention Strategy are identification of infected persons and
prevention of new infections. These objectives are paramount to
reducing the impact of HCV on the public.
Identification of HCV-infected persons as well as persons
at risk of HCV infection is best achieved through the
integration of hepatitis prevention services into community-
based clinical and public health programs that serve at-risk
persons. Because the majority of persons with hepatitis C do
not have symptoms of liver disease, their identification
requires that testing be done on persons with risk factors for
infection.
CDC has conducted a number of community-based demonstration
projects called Viral Hepatitis Integration Projects which have
shown the feasibility and the effectiveness of including
hepatitis prevention services in a variety of clinical and
public health settings.
I would now like to take a few moments to highlight some
specific components of the National Hepatitis C Prevention
Strategy.
First, as it relates to health communications, CDC has
developed evidence-based guidelines for identification and
testing of persons at risk of hepatitis C. CDC has also
provided a broad range of materials about hepatitis C for
health care professionals and the public. These include Web-
based, continuing medical education programs for health care
professionals, a Hepatitis C Toolkit for primary care providers
and their patients. We have brought with us samples of these
materials on the table here and there for those interested, and
it can also be found on CDC's Web site. CDC has also funded
academic centers, health departments and nongovernmental
organizations to carry viral hepatitis education and training
activities.
Second, with regard to community-based prevention programs,
currently, CDC funds 53 hepatitis C coordinators in States,
large metropolitan areas and in the Indian Health Service.
These coordinators work to accelerate the integration of
hepatitis C testing, counseling and referral for medical
evaluation into community-based programs that provide clinical
and Public Health Services. Among the many activities in which
the coordinators engage is the development of comprehensive
State hepatitis C prevention plans, and at least 23 States have
such a plan at this time.
Surveillance is another important component of the
prevention strategy because it allows us to monitor trends as
well as the effectiveness of prevention efforts. CDC continues
to work to develop and maintain enhanced national surveillance
systems for hepatitis C. Since 2003, chronic HCV infection has
become reportable to CDC; and CDC has developed surveillance
guidelines for case investigation and followup of persons of
chronic HCV infection.
As there continues to remain a number of an unanswered
questions concerning the epidemiology and the natural history
of HCV infection, CDC has a number of studies under way or
planned.
In conclusion, since 1998, CDC and its partners have made
considerable progress in raising awareness about the prevention
of hepatitis C both among health care providers and the public.
In addition, many States have initiated hepatitis C prevention
programs, which are being facilitated by the federally funded
hepatitis C coordinators. However, our job is far from complete
and much more remains to be done.
Thank you for your attention and for the opportunity to
increase awareness about hepatitis C for this hearing, and I
will be happy to answer any questions you may have.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Khabbaz follows:]
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Chairman Tom Davis. Dr. Hoofnagle, thank you for being with
us. It is a pleasure to have you. One of my staff members told
me that your efforts, at least she thinks, helped save her life
a couple of years ago, so thank you very much.
Dr. Hoofnagle. Thank you very much, Mr. Chairman and
members of the committee.
My name is Jay Hoofnagle, and I'm the Director of the Liver
Disease Research Branch for the National Institute of Diabetes
and Digestive and Kidney Diseases, one of the Institutes at the
National Institutes of Health. I'm pleased to be asked to
present testimony today on behalf of the NIH and its commitment
to research on hepatitis C.
As you have heard from Dr. Khabbaz, hepatitis C is a very
important cause of liver disease. Between 1 and 2 percent of
Americans are chronically infected with hepatitis C. Hepatitis
C is now the most common cause of chronic liver disease and
most common cause of cirrhosis and the major single cause for
liver transplantation in adults, and it has become the most
common cause of liver cancer in this country and most of the
western world.
But, also important, hepatitis C is due to a virus and, as
such, this is a potentially preventable, potentially treatable
disease. That means that control of this virus will go a long
way to the control of cirrhosis in this country.
We believe, Mr. Chairman, that the greatest promise for
ultimate control of hepatitis C will come through advances in
biomedical science and biomedical research, advances in the
means of diagnosis and evaluation and treatment and prevention
of this disease. Indeed, there are few areas of biomedical
research at present that are more likely to result in immediate
and tangible improvements in the health of Americans than
research on hepatitis C.
As you know, the mission of the NIH is to advance
biomedical research and thereby reduce the burden of disease
and improve health of Americans. Hepatitis C is a shared
interest at the NIH, not just by my Institute but also by the
National Institute of Allergy and Infectious Diseases, the
National Institute on Drug Abuse, the National Cancer
Institute, the National Heart, Lung and Blood Institute, and
the National Institute on Alcohol Abuse and Alcoholism.
The activities of the Institutes are coordinated through
multiple committees, so that in fiscal year 2004 that was just
completed the estimated total amount of NIH research on
hepatitis C was $118 million. Importantly, this figure is a
major increase from what was funded 5 and 10 years ago. For
instance, between 1998 and 2003, the Congress allocated funding
that allowed for the doubling of the NIH budget. During this
same time, the budget specific for hepatitis C increased almost
five-fold, stressing the importance of this research area and
the ability of the NIH to allocate funding to emerging
conditions of importance.
This hearing actually occurs at a special time for liver
disease research in that the NIH has just completed a trans-NIH
action plan for liver disease research. This is the result of a
year of work and input from over 250 investigators, physicians
and lay persons. It covers all of the diseases, but hepatitis C
is a major focus of this action plan. The action plan outlines
some goals and visions for the next 5 to 10 years of research
on liver disease, and some of my testimony will address the
goals outlined in that plan. So in this brief introduction I
want to discuss two areas of importance and research. The first
is treatment and the second, prevention.
As to treatment: The first treatment for hepatitis C was
licensed in 1991, and it is alfa interferons, given by
injection for 6 to 12 months. As originally formulated, this
regimen of therapy gave us sustained response in only 10 to 20
percent of patients at most.
During the last 5 years, we have been fortunate to see
several advances in therapy of hepatitis C, the first, the
introduction of the anti-viral drug ribavirin, and, the second,
the development of long-acting interferons that are given once
a week rather than daily or every other day and that are more
effective. So that the currently recommended regimen for
hepatitis C, the combination of peginterferon and ribavirin, is
effective in 55 percent of patients with hepatitis C who have
no other problems with their health. Indeed, in subgroups of
patients, patients who have different strains of hepatitis C,
strain 2 and 3, the response rate is greater than 80 percent.
These results are heartening.
Also heartening is the fact that what we call sustained
response is now shown to be durable and long lasting, and it
appears to be a cure of this viral infection. Well, that's nice
in a way, but remember that for 55 percent of these people that
respond, there are 45 percent who did not. This treatment is
difficult, and it's expensive and has many side effects.
Clearly, new approaches of treatment are needed.
A major proportion of our portfolio now in funding research
on hepatitis C is directed at improving therapy, and industry
is also involved in this to a major degree. There have been
more than 50 patent applications for new therapies of hepatitis
C, and at least six of them are in early human trials. These
are not ready for licensure or approval, but I can assure you
that they look very promising. It is our hope that in the next
5 to 10 years, we will have therapy for this disease that will
be effective in more than 90 percent of patients and will
extend to those difficult-to-treat populations that are a
problem at present.
Finally, as to prevention, as you have heard from the CDC,
currently, there are recommendations toward prevention based on
public health measures. Since the discovery of the virus in
1987, there has been an 80 percent drop of new cases of
hepatitis C. It is quite heartening. But since the 1990's, this
level of infection has stayed stable, and there has been very
little further decrease. What is needed? Clearly, specific
means of treatment are needed, vaccines and globulins that are
effective against exposure to hepatitis C.
In this regard, major efforts are being made in this area,
stimulated through workshops, initiatives, added funding, to
request of applications for basic research on development of
tissue culture, animal models and candidate vaccines. Phase one
studies of experimental vaccines have been funded, and with the
advances and knowledge about the immune system and with the
focus on this issue, we believe that a vaccine against this
disease will ultimately be available.
Mr. Chairman, let me conclude by thanking you for having
this hearing highlighting this very important disease and
express the gratitude of the basic and clinical research
community in general for the confidence and trust that the U.S.
Congress has put into us through continued support of the
National Institutes of Health and their mission. We believe
that real progress can be made in the control of hepatitis C,
and I will be glad to answer any questions that you have of me
on the issue.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Hoofnagle follows:]
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Chairman Tom Davis. Dr. Deyton.
Dr. Deyton. Thank you, Mr. Chairman and committee members.
We appreciate the opportunity to be here today.
Hepatitis C has been and continues to be a high priority
for the Department of Veterans Affairs. Veterans who use VA for
health care are affected by hepatitis C in greater proportion
than the Nation as a whole, and VA cares for more people with
hepatitis C than any other medical system in the country. VA
has established a comprehensive approach to hepatitis C similar
to that recommended by former Surgeon General Dr. Koop and
others in testimony before this committee 6 years ago.
VA's public health approach to hepatitis C contains five
integrated components that I will highlight: No. 1, screening
and testing; No. 2, patient and provider education; No. 3,
access to excellent clinical care; No. 4, data-based quality
improvement; and, No. 5, research.
First in the area of screening and testing, it is VA policy
to provide screening for hepatitis C risk factors for all
veterans who receive VA health care and to offer testing for
those with risk or anyone who desires to be tested. Since 1999,
Mr. Chairman, over 4 million veterans in VA care have been
screened for hepatitis C risk factors, and over 200,000 have
been diagnosed with hepatitis C infection. A recent external
review of over 50,000 medical records showed that over 98
percent of VA patients have been screened for risk factors, and
over 90 percent of those at risk have been tested for hepatitis
C.
VA leads the Nation in testing for hepatitis C. Our success
in screening and testing has its foundation in the second
component of our public health approach, that is, an aggressive
program of patient and provider education. We've provided to
your staff examples of our education program, including copies
of 29 single-topic patient education brochures on hepatitis. We
distributed literally millions of these brochures throughout
the VA health care system in order to inform veterans about
hepatitis C. We have partnered with veterans' service
organizations and various advocacy groups to promote hepatitis
C awareness. We have also conducted an aggressive provider
education program, including giving grand round lectures on
hepatitis C at nearly every VA hospital in the Nation. We have
held national education conferences attended by nearly 1,000 VA
health care providers. We have developed recommendations on
hepatitis C treatments and distributed them in print and
electronic form, on pocket cards and by software downloadable
into provider's handheld PDAs. In addition, we've identified a
lead hepatitis C clinician in every VA hospital in the country.
These are our main points of contact to transmit education and
treatment updates.
Identification of veterans infected with hepatitis C who
use VA health care system necessitates the third component of
our public health approach, and that is excellent clinical
care. Excellent clinical care for hepatitis C includes, one,
careful medical assessment of liver function; two,
identification of and treatment of important co-morbidities of
especially mental health, substance abuse disorders and HIV
infection. The third area is providing anti-viral drug therapy
when indicated, with close medical monitoring during the 6 to
12 months of therapy and treatment of its frequent side
effects, which Dr. Hoofnagle mentioned. The fourth area is
management and prevention of complications associated with
cirrhosis and end-stage liver disease when they occur and,
finally, liver transplantation when no other option exists.
The VA's hepatitis C resource centers program works to
improve clinical care, including regular updating of our anti-
viral treatment recommendations, expanding the population of
patients who can be safely treated for hepatitis C, increasing
skills of our liver specialists in managing the psychiatric
complications of hepatitis C treatment, and in managing
cirrhosis and end-stage liver disease, and expanding the cadre
of health care providers trained to deliver hepatitis C care
beyond liver specialists, who are in very short supply, to
include primary care providers, mid-level practitioners and
clinical pharmacists as well as development of guidelines for
establishing hepatitis C patient and family support groups so
important in successful care.
Anti-viral therapy is not recommended for all hepatitis C
patients, and some who are eligible turn it down because of the
potentially severe side effects, long duration of therapy and
relatively poor success rates of the currently available drugs.
Recently, VA has treated approximately 9,000 veterans each year
with anti-viral medications for their hepatitis C infection.
In addition, VA has an active liver transplant program.
Last year, over 400 veterans were evaluated for possible liver
transplant, and VA performed 87 liver transplants.
VA's national electronic medical records system allows us
the unique opportunity to undertake the fourth component of our
public health program for hepatitis C, that is data-based
quality improvement. In 2000, we established the National VA
Hepatitis C Case Registry. This registry tracks, in a
confidential manner, the detailed medical data on VA patients
who have tested for or have been diagnosed with hepatitis C.
This information helps both our national program and our local
clinicians improve the quality of patient care. Through the end
of fiscal 2004, over 273,000 veterans have been added to that
registry. This is the largest organized prospective collection
of clinical data on persons with hepatitis C in the world.
The final component of the VA public health program in
hepatitis C is to promote and support research to improve the
health of veterans living with hepatitis C. In fiscal 2003, VA
funded 15 projects at a cost of more than $2.4 million, and VA
investigators leveraged over $4.1 million in non-VA funding to
support 104 different hepatitis C research projects.
In conclusion, VA's comprehensive public health approach to
hepatitis C has been successful in achieving the goals outlined
to this committee 6 years ago. VA's approach to hepatitis C has
elements that may be useful for other large health care
systems, for health insurance companies, employers, public
health departments, private practitioners and the public at
large.
While proud of these accomplishments, we recognize much
remains to be done to identify veterans with hepatitis C and
provide
them with the best medical care possible. That is our
commitment to serve the men and women who have served our
Nation so nobly.
This concludes my remarks. Dr. Rigsby and I would be happy
to answer any questions about the VA program.
[The prepared statement of Dr. Deyton follows:]
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Chairman Tom Davis. I want to thank all of you for your
testimony and your work in this area.
Dr. Khabbaz, let me start. When HIV-AIDS was emerging, as
was noted before, and this is true with other diseases, a lot
more information and publicity were available about the disease
that seems to be lacking in this instance despite some efforts
on your part and others to try to increase awareness of this
and some of the preventive measures that people can take. What
do you attribute that to and do you have any thoughts about how
we change it?
Dr. Khabbaz. Thank you, Congressman, for the question.
HCV is, by and large, thought of as being a silent epidemic
in terms of a large number of people with asymptomatic
infections in the acute phase of the infection. And 75 to 85
percent of those go on to develop chronic infection, and
there's a subset that develop chronic disease. So it has been
around with us for a long time undetected.
As part of the National Hepatitis C Prevention Strategy,
identification of infected persons, prevention of the disease,
part of that strategy is putting information out. And CDC has
been working to put such information out. I mentioned the
brochures and the fact sheets, and we have worked with partners
as well to develop educational materials both for health care
providers and for the public.
Chairman Tom Davis. Do you think there are thousands of
people walking around that are infected now and have no idea
because the symptoms haven't appeared yet?
Dr. Khabbaz. That is one element out there, but, as I
alluded to in my remarks, the best approach to reaching those
people is integration of prevention programs, hepatitis
prevention programs into existing health and public programs,
and we have initiated that.
Chairman Tom Davis. And only 23 States have comprehensive
hepatitis C prevention plans today. That is a good way to get
at it, is to get the States involved. We had trouble to get a
State medical officer here today to testify. I know they are
handling a lot of different emergencies and so on, but that is
a problem and that is something we can look at from this area
in trying to put some incentive or stick in the hands of these
States so that they wake up. Would that be helpful?
Dr. Khabbaz. As I mentioned in my remarks, I think there is
more to be done. CDC has funded hepatitis C coordinators, 53 of
them in State health departments, and we have one with Indian
Health Service. And one important function of these
coordinators is to develop prevention plans, comprehensive
prevention plans. Correct, 23 States have those plans, and 5
other States are developing plans. CDC also provides assistance
to States and some of the plans are shared, available on the
Web site and shared with States to develop their own plans.
More needs to be done.
Chairman Tom Davis. Dr. Hoofnagle, currently, there is no
vaccine against hepatitis C. Why in the age of preventive
medicine is it so hard to develop an effective hepatitis C
vaccine? Do you think it is realistic to expect a vaccine in
the next 5 to 10 years? What can we do to help that along? Is
it a funding issue? What are some of the variables?
Dr. Hoofnagle. The problem is with the virus and how you
respond to it. The difficulty is that if you are one of those
lucky people who recover from hepatitis C, you are not
protected against reinfection. The antibody in hepatitis C--
this is nature and not something we did--is not very
protective. If nature can't do it, how can we come along and do
better?
Well, one clue is that 30 percent of people recover. Why do
they recover? It appears to be not just antibody. The usual
thing, that we stimulate with a vaccine like hepatitis A or B
vaccine, you get antibody. Maybe you also have to stimulate T
cells or other forms of the immune system to clear the virus.
This is the kind of new information that's arising, that
perhaps you can't get sterilizing immunity, but you can induce
parts of the immune system so that the person who gets exposed
and gets infected will recover on their own.
And I'm a little optimistic about a vaccine being
available. I think it might not be the typical type of vaccine,
like hepatitis A or B vaccine, but it would be a vaccine that
promotes recovery, and that might be almost as good as a
regular vaccine.
Chairman Tom Davis. Thank you very much.
Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman.
We are dealing with a disease that people wouldn't realize
they had for years, maybe even decades, is that right?
Dr. Hoofnagle. That's correct.
Mr. Waxman. And it suddenly would take hold? How would it
manifest itself if somebody had a reactivated hepatitis C?
Dr. Hoofnagle. Hepatitis C is a long-drawn-out disease and
causes inflammation and damage to the liver. You don't feel
your liver very much with inflammation. It is not like a sore
throat or a skin rash. You don't see it until the liver is
fairly badly damaged; and, at that point, it may be a little
bit late to do something or to treat. So if we wait for
symptoms to appear, we are waiting for the point that the liver
is starting to fail; and you need to do something about this
disease while there is just inflammation and a little bit of
damage to the liver. There are blood tests that show that the
liver is inflamed and ways to screen tests for those.
Mr. Waxman. So the obvious public health matter before us
is to try to get to the people who may have hepatitis C and get
them in to be tested and get them into treatment before the
symptoms manifest themselves.
Dr. Khabbaz, there was a group of people who had blood
transfusions prior to 1992. It is a discrete group. We know who
had blood transfusions prior to 1992. I guess the FDA did not
recommend a look back to notify those people who had those
blood transfusions prior to 1992. Many of them are infected and
don't realize it. From a medical standpoint, wouldn't it be
valuable to let these people know that they have hepatitis C
and that they should do something about it?
Dr. Khabbaz. Yes. As I mentioned, part of the hepatitis C
prevention strategy and an important component is identifying
people who are infected. And you are correct. Limited look-back
was initiated. However, the thought was that it was difficult
to reach people, most of the people, infected in terms of when
you look at blood transfusion basically before the mid-1980's
when a nonspecific test was introduced. Before that, there was
quite a bit of transmission via blood. And in 1992, when the
specific hepatitis C test was introduced, is when the
transmission dropped to less than one in a million. To reach
those people and reach the other groups at risk, one of the
important things is to make sure that clinicians, health care
providers routinely ask about risk factors, transfusion and
others, and then offer the test, as you have alluded to.
Mr. Waxman. I suppose when people came in for medical care
they might get this routine test as part of their physical
examination. But, as I understand it, most of the people who
now have hepatitis C are IV drug users. Sixty percent of the
people have hepatitis C. I doubt many of them come in for
medical care.
I know CDC is trying to reach people and inform them. If
you have a group that could be contacted directly, it seems to
me there is a moral argument to contact them. If you don't do
that, the strong argument then is to have a public education
campaign. If CDC had more money, would you be putting money
into trying to inform the public of the risks that they may be
having with hepatitis C and get them in for the tests?
Dr. Khabbaz. Let me make a few comments.
In terms of reaching people and reaching the groups that we
know of for hepatitis C, you know, we feel that people do see
providers for a number of reasons. So, basically, the approach
to educate health care providers not just in the private sector
but the public sector as well and the demonstration projects
that we have had, the viral hepatitis integration projects to
provide care, you know, screening and testing and then forward
patients for management and all that sort of thing within the
context of programs that provide care, a comprehensive approach
has been shown to be feasible and effective. That is one
component. There is public education material that we put out.
Thirty thousand separate materials are requested from the CDC.
Mr. Waxman. Let me interrupt you, because the light is on.
I have time for one more question, and I wanted to ask Dr.
Hoofnagle a question.
It seems to me one of the strategies ought to be,
especially if we have all these IV drug users, we ought to
discourage them from using drugs, which means get them into
treatment programs. But, second, if they are not going to be
into a treatment program because the program is not available,
wouldn't it be wise for us to have them use clean syringes and
have the government make that available? That was one of the
recommendations that was given by the National Institutes of
Health group that looked at this whole problem. Don't you think
that would make sense from a public health point of view?
Dr. Hoofnagle. I have to defer to my CDC people about
public health issues. The consensus conference was not
officially the Federal Government. They are an independent
panel the Federal Government calls together.
Mr. Waxman. That make it even more credible, doesn't it?
Dr. Hoofnagle. It does.
Mr. Waxman. And they recommended we have a clean syringe
program. Doctor, do you want to respond to that in the time
that I don't have available to me?
Dr. Khabbaz. In terms of drug treatment centers, this is a
good place for primary and secondary prevention for hepatitis
and other blood-borne infections. In my understanding, in terms
of the harm reduction interventions, while they make sense, it
has been shown to be effective for HIV but are lacking for HCV.
There are some differences in the epidemiology when you look at
drug users in terms of, even though they are all blood-borne
infections, but in terms of who gets them there and how, there
are some differences out there. Quickly after starting drug
use, people get them, and it takes a long time.
Mr. Waxman. Wouldn't sterile syringes and safe injection
practices decrease the public health problem for HIV and
hepatitis C?
Dr. Khabbaz. Strategies and prevention programs to drug
users would seem to make a difference, I would think.
Mr. Waxman. Thank you.
Chairman Tom Davis. Thank you.
Ms. Norton.
Ms. Norton. I have a great respect for science in this
country, and I'm bothered we can't get a straight answer on Mr.
Waxman's question. If something can be transmitted by dirty
needles, the question is you say to a scientist, you say to a
doctor, would it be better to have an exchange of clean
needles?
I want to quote from the NIH consensus panel: Urge the
government to institute measures to reduce transmission of
hepatitis C virus among intravenous drug users, including
providing access to sterile syringes through needle exchange,
physician prescription and pharmacy sales. May I just ask both
of you, do you agree with that recommendation of the NIH
consensus panel? I'm asking you as doctors, do you agree with
that or are you in disagreement with what this panel has said?
Dr. Hoofnagle. No, I'm in agreement that would be a good
policy.
Ms. Norton. Dr. Khabbaz, are you in agreement or
disagreement with what these experts in this field have said?
Dr. Khabbaz. Again, I don't disagree, as I told Congressman
Waxman, that those and other harm reduction interventions make
sense and it would be helpful. I don't, for hepatitis C
specifically--and Dr. Mast can add to my comments--I'm not
aware that it shows it is effective.
Ms. Norton. This is what this panel has said. The reason I
ask is because it is very bothersome. The one set of people I
expect to get straight answers are people that base their
information on science. I'm not asking whether you are for it
or against it. I'm asking you whether this is a way of
preventing the spread of what you yourself have said is a
silent killer. I'm asking you as a doctor and as a scientist.
And Dr. Mast, if you want him to----
Chairman Tom Davis. Will the gentlelady yield? I would like
to throw something in the mix. I ask unanimous consent that the
gentlelady from the District be given an additional minute, and
I will just intervene to opine a question.
This is an issue we have fought over up here, needle
exchange programs, and argued about, particularly with the
District of Columbia. I have always had some concern that if
you are a veteran and go to a veterans hospital we charge you
for a needle. If you are an average Joe, you go to a hospital,
they charge you for a needle. If you are on Medicare, they
charge you for a needle. But if you are using illegal drugs,
they give you a free needle and what are the policy
implications of that.
We understand that using a clean needle is better for you
than using a dirty needle, and we agonize over this, and in
different parts of the country, jurisdictions react
differently. I think the way we have dealt with it in the
District is we decided they could do what they wanted to do
with their own money and not use Federal money, and it seemed
to work itself out but not without a lot of debate.
The gist of the question is--and maybe you are not in a
position overall to say what the ramifications are to the
message of giving out free needles when you are trying to get
people to stop using drugs altogether. But, clearly, a clean
needle is better than a dirty needle. We argued about this,
too, because we have competing policy goals.
Dr. Khabbaz. I don't disagree. I agree.
Ms. Norton. I'm looking for a way to get at the silent
killer. I was interested in the testimony from you, Dr.
Khabbaz: Current anti-viral treatment completely eliminates the
infection in 50 to 55 percent of selected patients, with 95
percent of those remaining free for--virus free for 5 years.
That would seem to put a premium on getting some people before
this progressive liver disease and all the attending
consequences.
I'm looking for signs of a national campaign, and I have
spoken of my ignorance of this disease. I think it's your
testimony, Dr. Hoofnagle, about outreach and public education
efforts, and the testimony at page 7 talks about coordinating
focus provided by the National Digestive Diseases Information
Clearinghouse--I kind of don't understand that, but perhaps you
could explain why that is a clearinghouse. I don't much care,
but that's interesting. I didn't think of this as a digestive
disease. But, moving right along, including the involvement of
multiple NIH agencies, other Federal agencies, professional lay
organizations. And online you have two NIH Web sites. I can't
find a focus for this disease. I can't find somewhere in NIH or
in CDC, somewhere in the Federal Government where somebody
regards it as his mission to educate the public that millions
are walking around with this silent disease or to tell people
that we actually can do a great deal if you get to us early, as
your testimony has indicated.
So I am looking for who it is who is in charge of helping
us to spread the word to eliminate the disease, to get people
into treatment, and the rest of it.
Dr. Hoofnagle. Well, what you are referring to there is the
NAIAD Digestive Disease Clearinghouse, which is the mechanism
we use to provide information to people, to physicians,
doctors, interested in the diseases that we are involved in as
far as research. It is not mandated as an educational program
to go out to all Americans. It's largely a mechanism that we
use to get out information.
Ms. Norton. Who is it that is in charge of getting the word
out to average Joes like people on this panel?
Dr. Hoofnagle. Well, I would turn to my colleagues here at
the CDC again about that.
Dr. Khabbaz. I've alluded to the efforts that we have in
the health communication arena. Let me just expand. I've
already mentioned we have the brochures and posters and
pamphlets and information on hepatitis C for health care
providers and for the public, are available and have been
translated into Spanish and Russian, and about 30,000 separate
pieces of such educational material are actually distributed
each month on request to the public and doctors. There's also a
tool kit that was developed for physicians and their patients
and about 143,000 providers have received this tool kit.
There's a hotline. The CDC funds cooperative agreements with
nongovernmental organizations, academic centers, and health
departments to develop training and education materials and to
evaluate them. And so there's a lot of material being developed
by CDC and by partners and others.
I would also mention the roundtable that CDC has initiated
to bring together all the partners working in this arena,
governmental and nongovernmental organizations, to make sure
that we are all coordinated in terms of information and
approach to prevention.
Chairman Tom Davis. Thank you. This is the last question.
Go ahead and answer if you want to.
Dr. Mast. Ms. Norton, we agree with you that health
education and communication is a major component of the
National Hepatitis C Prevention Strategy, and CDC has developed
a broad range of materials both for the general public, for
persons at risk, and for health care providers. We've done our
best to make those materials accessible to people and will
continue to do our best to make those materials accessible to
people.
Chairman Tom Davis. Thank you very much. Mr. Towns.
Mr. Towns. Thank you very much, Mr. Chairman. Let me begin
with you, Dr. Khabbaz. Why is it that CDC does not require all
States to provide surveillance on hepatitis C?
Dr. Khabbaz. That is an important question. Actually
surveillance for hepatitis C has a number of components. With
regard to acute hepatitis, acute hepatitis C, it is reportable
actually, and the organization that makes the disease
reportable is not CDC. It's the Council of State and
Territorial Epidemiologists that actually have representatives
of State epidemiologists, the ones who decide on a disease
being reportable, and then States adopt its recommendation. So
acute hepatitis C has been reportable for many years, and so we
gather and put out reports and follow trends of disease. And in
2003 actually, working with the Council and State Territorial
Epidemiologists [CSTE], chronic hepatitis C viral infection has
also become reportable, and 19 States have actually provided
reports. There are challenges to doing chronic hepatitis C
surveillance in terms of gathering----
Mr. Towns. Nineteen States.
Dr. Khabbaz [continuing]. And verifying these reports and
clearly more States need to come on board, and that work is
going on to train and to provide investigation material and
all. So we have made progress but there's more to do, as I
mentioned earlier.
Mr. Towns. You know, let me just say I don't feel there's a
sense of urgency here. I hate to say that but just sort of
casually 19 States out of the 50, maybe next year there will be
20, and this just sort of casual kind of thing, that really
bothers me, because we're talking about a life and death issue.
And I'm disturbed by it.
Let me ask again, in your testimony you note that States
have initiated hepatitis C prevention programs and that these
programs use Federal funds. Let me ask this: The number of
States that have such programs, you indicated, the amount of
Federal funds allocated per program, could you tell me that,
the amount of money allocated?
Dr. Khabbaz. I don't have the numbers with me but will be
glad to give you those numbers.
Mr. Towns. Mr. Chairman, could we leave the record open to
receive that information?
Chairman Tom Davis. Could you try to get that to the
committee, and we'll keep the record open for that. Thank you.
Mr. Towns. The other question is do States have to match
these funds?
Dr. Khabbaz. My understanding, and Dr. Mast may want to
elaborate some more, is that these funds are made available
through cooperative agreement. So States do not have to match
funds. Funds are made available to support programs in
prevention, State coordinators, education and surveillance.
Now, many States have actually put in funds and supplemented
those Federal resources to carry out hepatitis C prevention
activities, but they're not mandated to do so.
Dr. Mast. The basic concept is we fund a single hepatitis C
coordinator in every State and their responsibility is to
integrate hepatitis C activities into existing State programs.
So they work with other communicable disease programs, with
STD, HIV programs to integrate hepatitis C activities into
existing State programs. So that's the concept that we're
promoting.
Mr. Towns. The reason why I'm asking is I'm trying to
figure out why every State would not want to have one.
Dr. Mast. We offered funding to all States to have a
hepatitis C coordinator, and all but two States have requested
and are currently funded.
Chairman Tom Davis. Can I just ask which two States haven't
asked?
Mr. Towns. Yes. Which two States?
Dr. Mast. The two States that currently don't are Kentucky
and South Dakota.
Mr. Towns. Let me get Dr. Hoofnagle. Can you tell us about
the Federal Interagency Working Group? I need to know a little
bit more about that hepatitis C working group.
Dr. Hoofnagle. The hepatitis C working group is an informal
group of people from each of the institutes that funds research
on hepatitis C that get together to coordinate our initiatives,
if we have a new idea like, say, put together a workshop to see
which other institutes would be interested in contributing.
Mr. Towns. I see my time has expired, Mr. Chairman. So
thank you very much.
Chairman Tom Davis. Thank you very much. Let me just thank
this panel. We've got another panel we are going to go to and
hear from them, some of the personal stories, but I want to
just thank you all for----
Ms. Norton. Mr. Chairman, could I ask one moment----
Chairman Tom Davis. Without objection, Ms. Norton, you can
ask another question.
Ms. Norton. The reason I asked about a national campaign,
it has to do with statistics that show that 60 percent of those
infected are intravenous drug users. I hope that you will take
back to CDC, particularly given your answer on what kind of
campaign you're conducting, posters and the rest of it, and,
you know, a lot of these people are in jail. They will come
home to communities like the District of Columbia. They're
going to come home to the big cities and spread this disease,
and we don't know anything about this disease in this city.
Their own Congresswoman doesn't know anything about it, and I
would imagine that I'm like many other Members of Congress and
many other people who run cities, and I am going to ask you,
based on your testimony today, whether you would take back to
CDC the need to do a real national campaign so that we can
apparently make available treatment which could keep this
disease from progressing.
You have testified it's a preventable disease, and I have
to tell you I don't think you're doing anything to help us
prevent this disease, which even those of us who ought to know
better don't know, and we need a campaign to reach people who
are in jail, to reach people who are inclined to take drugs,
and campaigns about posters and the rest of it clearly are not
doing the job as these figures go up, and I just have to leave
you with that message and hope you will take it back and try to
come forward with a campaign.
Chairman Tom Davis. Let me ask, Dr. Deyton, we didn't get
really into the success you have had at VA on this, but what
elements of VA's hepatitis C program could be exported to the
general public do you think?
Dr. Deyton. Certainly, Chairman Davis, the educational
materials that we've developed and distributed throughout the
VAs around the country for both patients, their families, and
providers are publicly available. They're on our Web site, and
we're happy to make them available to anyone else.
Chairman Tom Davis. So we don't have to reinvent the wheel
on this case?
Dr. Deyton. No, sir. No, sir. And these materials are
already being used by CDC and NIH. It's just a matter of
getting it in the right hands. And I have to say that I think
that the VA's success, and we've still got a ways to go, but
the VA's success is--it's a multicomponent issue. It's the
screening and testing, it's the education, it's the care, but
it's a partnership, Mr. Chairman, between the health care
system and the public and our national leadership and advocacy
groups. We in the VA have been very lucky that this is an issue
that the veterans service organizations, Vietnam Veterans of
America, and specific advocacy groups around this issue, some
of which are here in this room today, have been passionate
about for some time, and it's given us a lot of external
support to do what we knew we needed to do. So I think it's a
marriage, sir, and many components, including leadership from
communities, from Governors, from health directors, health
department directors, etc., are very important to get this
important disease into the public's mind.
Chairman Tom Davis. Thank you.
Mr. Waxman.
Mr. Waxman. Mr. Chairman, Dr. Deyton's point I think is
well taken, but I would point out that the veterans health
system is an integrated approach to screening, diagnosis, and
treatment, and for people who are not part of the VA, it
doesn't work like a system. Others with hepatitis C, even if
they have health insurance, often struggle to get the care they
need. We don't often find ourselves in an integrated health
care model.
I would like to ask two things for the record. Dr. Khabbaz,
there was a National Hepatitis C Strategy, and I'd like to have
you supply for us what elements of the strategy have not yet
been implemented because I assume that everything has not yet
been implemented; otherwise we wouldn't be holding a hearing
today about how this problem is still a major concern.
Chairman Tom Davis. You can followup on that and we'll put
it in the record.
Mr. Waxman. Yes. So this will be furnished to us for the
record of those elements of the strategy that have not yet been
fully implemented or funded.
And third, Mr. Chairman, Congressman Cummings and I
recently wrote NIH Director Dr. Zerhouni about harm reduction,
and I would ask that his response on the effectiveness of harm
reduction be placed into the record for today's hearing.
Chairman Tom Davis. Without objection.
[The information referred to follows:]
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Mr. Waxman. Thank you very much.
Mr. Towns. Let me ask for the record as well, of the $118
million, Dr. Hoofnagle, how much was actually spent, for the
record? You don't have to tell me today. For the record. And
what kind of correlation exists between NIDDK and the other
agencies and institutes within NIH that are doing hepatitis C
research? How are these research dollars being used? Can you
give me some percentage on the amount devoted to basic
research, the amount devoted to treatment, the amount devoted
to the vaccine? I'd be delighted if you would submit that for
the record.
Chairman Tom Davis. We will try to get that as well. Any
other comments you would like to make? If not, you don't have
to.
Dr. Khabbaz. I just wanted to thank you for bringing
visibility to hepatitis C, and I want to thank Miss Stein for
her interest and for bringing us here today.
Chairman Tom Davis. She has been great. We're going to hear
her on the next panel, what she and a group at Robinson High
School are trying to do.
Thank you all very much, and we'll take a 3-minute break
and then move to the next panel.
[Recess.]
Chairman Tom Davis. We're ready to move to the second
panel. I want to thank our witnesses for appearing. Invited to
join us on our second panel is Dr. Michael Rudman, the founder
of the Frederick County Hepatitis Clinic. Dr. Rudman will
provide the committee with an assessment of current Federal
efforts to combat hepatitis C. Ms. Ann Jessie, the Founding
Executive Director of the Hep C Connection, she's here to
discuss the potential costs of an inadequate response to
hepatitis C and support systems available to people living with
the disease. Captain John Niemiec, the first vice president of
the Fairfax County Professional Fire Fighters and Paramedics,
is here to discuss the risks posed to first responders and the
necessity of education about the disease. And last but
certainly not least, Ms. Erika Stein, from Robinson Secondary
School, is with us today to tell us her personal story of her
efforts to raise awareness and increase funding of prevention
and research of hepatitis C, and we have some of her Robinson
classmates here with you today.
Could we have you stand up, and just say thank you very
much. We waited until 2 p.m. for the hearings so they could get
in a full day of class ahead of time.
Dr. Rudman, why don't we start with you and we'll move on
down. Thank you for being with us.
Dr. Rudman. Thank you, Chairman Davis, for giving me the
opportunity to share with you something of what it's like to
provide medical care for people with hepatitis C and to share
with you my assessments of the effectiveness of the current
Federal efforts to----
Chairman Tom Davis. Dr. Rudman, I've just been reminded I
need to swear all of you.
[Witnesses sworn.]
Chairman Tom Davis. You can proceed.
STATEMENTS OF MICHAEL RUDMAN, M.D., FOUNDER, FREDERICK COUNTY
HEPATITIS CLINIC, INC.; ANN JESSE, FOUNDING EXECUTIVE DIRECTOR,
HEP C CONNECTION; JOHN NIEMIEC, FIRST VICE PRESIDENT, FAIRFAX
COUNTY PROFESSIONAL FIRE FIGHTERS AND PARAMEDICS; AND ERIKA
STEIN, ROBINSON SECONDARY SCHOOL DECA STUDENT (FATHER HAS
HEPATITIS C)
Dr. Rudman. Since March 2000 I've been the Medical Director
of the Frederick County Hepatitis Clinic. This is a small not-
for-profit community-based organization in central Maryland
that has provided comprehensive medical care to victims of
hepatitis C, care without regard to insurance or financial
status. We have now treated over 1,000 patients for hepatitis
C, most of them coming from marginalized populations that have
no other access to care.
Our patients come from as far away as Colorado, Florida,
Tennessee, Louisiana, Pennsylvania, West Virginia, and the
extremes of Maryland. They come because they're sick or because
they are afraid, or both, and they come to us because they have
nowhere else to go.
The majority of people with hepatitis C will not suffer
serious effects from the disease; however, a significant
minority will. Dr. JB Wong and others have projected that in
the decade of 2010 to 2019, 190,000 Americans will die of this
disease and this will represent a loss of 1.83 million years of
human life under the age of 65. Dr. Wong's group modeled the
economic cost of the epidemic and put it at $75 billion in
health care and societal costs. Now, that's for the decade to
come. This decade will be almost that high. Twenty percent of
the people with chronic hepatitis will get cirrhosis. That
represents 540,000 Americans. Reducing the disability and death
from HCV is the goal of our clinic. Each number represents a
human life, a world full of sensibilities and possibilities.
It seems like everyone I talk to sees this as a question of
money or the lack of it. Let me tell you what our clinic in
Frederick County has done with an annual budget of $60,000 to
$70,000 with one full-time employee, with a few part-timers and
a bunch of hard-working volunteers.
Last year, thanks to our strategic partners, including
Frederick County physicians, the Frederick Memorial Hospital,
Frederick County Health Department, Schering Plough, Roche, and
other pharmaceutical companies, and a grant from our Board of
County Commissioners, our clinic distributed $1.5 million in
goods and services to our target populations. As small and as
fragile as we are, the clinic is now one of Maryland's largest
hepatitis providers and is the only source of comprehensive
hepatitis care dedicated to Maryland's uninsured and
underinsured. Imagine what could be done with adequate funding.
Most federally funded HCV studies have not carefully
examined how the disease is expressed in marginalized
populations. Indeed, many of these people were excluded from
the NHANES survey upon which our current estimates of disease
prevalence are based. These people are truly invisible both to
the Federal Government and to academia. They're also where the
burden of this disease, its prevalence, disability, and
mortality, is concentrated. Our clinic targets these special
populations infected with hepatitis C, the poor and working
poor, the chemically dependent, the mentally ill, and HIV
coinfected. They comprise a little over half of our clientele
and our experience in dealing with special populations suggests
that HCV tends to be especially virulent in them; that is, more
likely to produce disability and death. Effective interventions
such as screening, education, vaccination and treatment, may
reap even larger benefits in this population than in the
general public.
When each client first arrives at our clinic, we do a
comprehensive health assessment. One of every 16 people arrives
at their first visit with end-stage liver disease, too late for
much of anything except comfort measures, transplantation, or
death. Our goal is to prevent this from happening in the other
15. We educate, counsel and support our clients. People who are
headed for cirrhosis get antiviral therapy.
Of the clients that our clinic selects for treatment, 48
percent have the most severe stages of viral hepatitis, stage
III and stage IV fibrosis. This is an important indication of
just how sick this invisible population is. There are hundreds
of thousands of people all over the country with stage III and
stage IV liver disease right now that are not getting any
counseling, not getting any treatment. Our clients often have a
history of substance abuse and/or psychiatric problems, and we
have to optimize treatment for these co-occurring illnesses
prior to, during, and after treatment. This is the challenge
and the dividend of treating HCV, its special populations. The
way we look at it, helping our patients to become healthy means
more than just curing hepatitis C.
Because antiviral treatment can be difficult, we provide a
lot of support for our clients, and the result is that 85
percent of those who start therapy finish it and the majority
of them who finish it eliminate the virus permanently. For them
treatment is a once and done deal. Today HCV is the only
chronic viral infection that can be called curable.
Chairman Davis, you asked for our comments on the Federal
efforts to combat this disease. Your Honor, if I could use your
combat metaphor, let me describe the situation from the point
of a view of a lowly platoon leader in the battlefield of HCV.
Sir, our troops are getting hammered. The battle plans that
have been drawn up in the form of NIH consensus statements and
CDC guidelines have not been implemented. The few units that
remain in action must scrounge for food and ammunition in the
wilderness. Let me illustrate these points from my experience
as a Maryland physician.
The State of Maryland, mind you, is not a poor State. We
are national leaders in biomedical research and in medical
education. Our Governor, Robert Ehrlich, a distinguished former
Member of the House of Representatives, is Maryland's first
Governor to begin addressing hepatitis C, and we're very
excited about this. However, let me share with you a few
surprising facts about the past, present, and future of HCV in
Maryland, a state of affairs which our Governor inherited.
I serve as a current member on Governor Ehrlich's Hepatitis
Advisory Council, and I have learned a lot about how Maryland
sees this epidemic. HCV is Maryland's second most commonly
reported infectious disease. It already has affected 100,000
Marylanders, of which or whom at least 20,000 will develop
cirrhosis and 5,000 will die. It will cost the State over $2
billion in health care and societal costs over the coming
years.
Yet Maryland's Department of Health and Mental Hygiene,
following the Federal Government's lead on HCV, has not one
person in the entire government designated to work on HCV, not
one. We do not have a hepatitis coordinator. In the 16 years
since the virus has been identified, the State of Maryland has
yet to spend $1 for HCV control or HCV education. Maryland
presently denies 90 percent of its 8,000 to 10,000 HCV infected
prisoners access to any screening, any education, or treatment
for HCV. Maryland does get Federal funds to treat HCV and co-
infected patients; that is, patients with HIV. You see, HCV is
a major cause of death in HIV patients and the Federal
Government provides funding for HIV and some of that could be
used to treat HCV, but only if you have HIV. HCV patients who
don't have HIV get nothing. They have the right to remain
permanently silent, the right to die of a treatable disease.
Congress can improve its efforts in combating HCV and other
infectious diseases by addressing the process by which health
care funding is allocated, making certain that the diseases
that are the most prevalent, costly, lethal, and responsive to
intervention receive priority funding. However, effective HCV
intervention will require a lot more than Federal funds. It
will require a degree of cooperation between mental health,
addictionology, prison, and public health, and infectious
disease disciplines that have never before been achieved. It
will require the development of fully integrated cross-cutting
teams that work well together instead of competing at the
Federal trough for funds, and unless this type of platform for
cooperation is crafted into the wording of funding proposal
goals and objectives, the results will be suboptimal.
Congress may want to look at allocating funds for HCV
training programs and primary care teaching settings. Family
practice, internal medicine, nurse practitioner, and
physicians' assistant training programs can easily integrate
HCV treatment into existing in-house substance abuse, STD, HIV,
and mental illness programs to provide the total package
necessary for optimizing clinical outcomes, and graduates for
these programs will then go out into the community and provide
good service for years to come.
On behalf of all the people with HCV and their families and
their friends and the doctors who struggle to treat it, I
respectfully implore you, Congressmen, please help us. We need
your help, not just Federal funds but Federal leadership, and
we need it now. Thanks for your attention.
[The prepared statement of Dr. Rudman follows:]
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Chairman Tom Davis. Thank you very much.
Ms. Jesse.
Ms. Jesse. My name is Ann Jesse. I'm both the founding
member of the National Hepatitis C Advocacy Council, a national
coalition of hepatitis C advocacy organizations, and also the
Founding Director of Hep C Connection, a national nonprofit
network support system for people living with hepatitis C. I
thank you, Mr. Chairman, for the opportunity to once again
address this grave public health threat before the Government
Reform Committee.
I remember well when shortly after my hepatitis C diagnosis
in 1994, former Surgeon General Dr. C. Everett Koop described
the hepatitis C epidemic as one of the most significant
preventable and treatable public health problems facing our
Nation. At that time he said it was a graver threat than the
AIDS crisis. Despite the ominous warnings of experts like Dr.
Koop and his successor, Dr. David Satcher, the general public
and many people in the health care and public health
communities still remain uninformed about the threat imposed by
the current hepatitis C crisis.
As early as 1991, Dr. Miriam Alter of the Centers for
Disease Control and Prevention warned us that hepatitis C was a
sleeping giant. Although others soon realized the far reaching
personal and societal threats posed by this sleeping giant, the
warnings were not acted upon with sufficient rigor to contain a
problem of such magnitude. So today we are faced with a public
health crisis that is growing day by day. This crisis will
continue to grow in destructive capacity for the foreseeable
future until we meet this foe with sufficient funds and the
rigor to control it.
To be sure, the alarm must be sounded. Based on incidence
and prevalence data and our current knowledge about the
clinical course of hepatitis C, we can expect that of the 5
million people estimated to be infected, at least 1.25 million
will develop cirrhosis and 125,000 will require liver
transplantation for liver failure and/or liver cancer. To give
you some frame of reference to comprehend the magnitude of
these figures, think of the number of people in a city the size
of New Orleans, Los Angeles, or San Antonio, TX. Now try to
imagine that every man, woman, and child in the city is
suffering from hepatitis C-related cirrhosis of the liver. That
is what this treacherous giant called hepatitis C has in store
for us unless we act immediately to intervene in the public
health crises.
Another way to comprehend the magnitude of the problem is
to consider how the number of people infected with hepatitis C
compares to other well-publicized health problems with which we
are very familiar.
We have the sign over here. HIV is notably absent from this
graphic over to my right. The reason is that because of the way
HIV/AIDS is reported, it is currently not possible to determine
how many new infections occur each year. However, according to
the CDC, an estimated 570,000 people in the United States were
living with HIV/AIDS in 2003 compared to an estimated 3 to 5
million people living with chronic hepatitis C. I think this
statistic is always amazing and alarming to the general public.
We must take control of the crisis and look at integration
into preexisting programs, but this alone is not adequate. The
National Hepatitis C Advocacy Council appreciates the fact that
there are several individuals in the Department of Health and
Human Services who understand the magnitude of the hepatitis C
crisis and are willing to dedicate the efforts needed to
intervene effectively. However, those of us who understand the
urgency of the crisis have been stymied because the response at
the Federal level to this crisis has thus far been starkly
insufficient to deal with the magnitude of the problem. We feel
strongly that an effective disease control and prevention
program must be tailored to fit the specific characteristics of
the disease being targeted.
In other words, effective programs are disease specific and
take into account the characteristics of the disease, such as
how it is transmitted, the national course of the disease, the
population at risk, and available treatment options. Herein is
the foundational problem with the current DHHS plan which
attempts to address the hepatitis C crisis solely by
integrating Hep C prevention control into preexisting HIV/AIDS
and sexually transmitted disease programs. Although HCV and HIV
have some shared routes of transmission, they are distinctly
different viruses and diseases. The risk groups and relative
risks of acquiring these two very different viruses from
certain activities are simply not the same. An integration-only
approach we feel is doomed to failure.
Should HCV prevention and control efforts be integrated
into existing HIV/AIDS and STD programs? Of course. But HCV
prevention and control efforts must go far beyond integration
if we hope to bring this crisis under control. In terms of the
potential costs of the inadequate response, I can assure you
that the hepatitis C crisis grows more seriously each day.
A landmark study published recently by Dr. John Wong, to
whom Dr. Rudman referred, laid forth the dire consequences of
the currently unchecked hepatitis C crisis. He predicted
several devastating personal, societal, and fiscal
developments, and I believe we have that to our right again.
The accuracy of Dr. Wong's predictions are already declaring
themselves in the rising rates of chronic liver disease,
increased incidence of liver cancer, and increasing demand for
liver transplantation. We are only at the beginning of this
devastating course. It will grow far worse unless we take
immediate action to change the current tide.
The good news is that we have not yet squandered our
opportunity to change the ultimate outcome of this public
health crisis. In the past decade great advances have been made
in the treatment of hepatitis C, and with the appropriate
therapy nearly 50 percent of those treated for their disease
are able to successfully clear the virus and halt further
disease progression. If we act now and successfully identify
and treat those at greatest risk for the development of liver
failure and/or liver cancer, we can save lives, salvage
productivity and ultimately decrease the burden of this
disease.
Unlike HIV, which requires life-long antiviral therapy, the
treatment for HCV is limited. A successful course of therapy is
completed in 24 to 48 weeks. For those who clear the virus know
that additional antiviral therapy is required. For all intents
and purposes these patients have been cured of chronic
hepatitis C.
The bottom line is that identifying and treating hepatitis
C is clearly cost effective, and we have those figures again to
the right.
Hepatitis C national advocacy and community-based
organizations have put forth heroic efforts to try to provide
much needed intervention and control services. Funded virtually
exclusively by private fundraising and small nonFederal grants,
the organizations of the National Hepatitis C Advisory Council
have conducted local screening, counseling and testing
programs, worked with corrections facilities to improve Hep C
efforts for the incarcerated population, collaborated with harm
reduction programs to provide Hep C education to at-risk
populations, authored a comprehensive patient-oriented book
about Hep C, and countless other daily efforts by a legion of
unsung heroes across the land. We are doing the best we can on
what amounts to a wing and a prayer and a passionate commitment
to those afflicted with this disease, but we are sadly aware
that our efforts are barely scratching the surface of what
needs to be done to address the crisis.
We, the DHHS agencies, the State and local health
departments and the Hepatitis C advocacy organizations, must
have funding to do the work we know must be done and that we
are fully prepared to do. Hepatitis C is everyone's disease.
Many of the millions of Americans infected with HCV are average
citizens just like you and me, our family members and friends:
Middle-aged working class men and women who may have had a
blood transfusion due to surgery, injury, or childbirth; young
adults who had transfusions as premature babies; military
veterans of Vietnam, Desert Storm and the young men and women
coming home from Afghanistan and Iraq; hard-working productive
men and women who experimented briefly with drugs in the folly
of their youth and are now paying the price.
Unlike most viral diseases from the common cold to
influenza to AIDS, HCV is a treatable illness. In other words,
unlike many other afflictions, we have the opportunity to
intervene in this crisis with a potential to achieve a viral
cure in approximately half of those treated. We have a rare
opportunity with HCV, and we must not squander it.
I am one of the many faces of hepatitis C and I stand
before you today as one of the lucky ones. Not only am I a
treatment veteran but I am also a successful responder to
treatment for this insidious disease. Unlike so many
unsuspecting people infected with hepatitis C, I was fortunate
enough to get tested, and unlike many people currently
struggling with hepatitis C, I had adequate insurance coverage
and was thus able to afford treatment. Above all, I was
fortunate to have successfully cleared the virus and remain
virus-free 6 years later.
In gratitude for my good fortune, the misfortune of the
millions of others infected with hepatitis C, not to mention
the more than 2 million Americans who are not aware they are
infected, that misfortune is never far from my mind. I cannot
forget about them and neither should you. Just as I pled for
attention before this same congressional committee in March
1998, I repeat my plea with even greater passion today. We have
a moral, professional, and fiscal responsibility to the
American people to act now to implement a fed-
erally funded comprehensive hepatitis C prevention and control
program. It is not only our responsibility, it is the only
humane option possible.
Thank you for your time and attention.
[The prepared statement of Ms. Jesse follows:]
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Chairman Tom Davis. Thank you very much, Ms. Jessie.
Mr. Niemiec, thanks for being with us.
Mr. Niemiec. Good afternoon, Mr. Chairman. My name is John
Niemiec, and I'm a captain with the Fairfax County Fire and
Rescue Department. I appear before you today on behalf of my
department and the Fairfax County Professional Fire Fighters
and Paramedics-International Association of Fire Fighters Local
2068, and my colleagues from the Fairfax County Sheriff's
office.
I would like to thank you, Congressman Davis, and the
committee for holding this important hearing today, and I
commend you for shining a spotlight on a public health issue
that is of vital concern to the Nation's fire fighters.
I would also like to thank Mr. Jay Walker, the students
from Robinson High School, DECA, and especially Erika Stein for
their unselfish campaign in promoting hepatitis C awareness and
future legislation.
I am here today because Hep C is a real concern for first
responders. Because hepatitis C is transmitted blood to blood,
first responders face an increased risk of exposure to the
virus. Hep C can be a lethal virus that is five times more
prevalent here in the States population compared to the HIV
virus, and yet, the American people receive little information
as it relates to the hepatitis C virus. The Centers for Disease
Control and Prevention estimate that approximately 1 out of
every 50 Americans, that is 1 out of every 50 Americans, is
infected with hepatitis C virus. Individuals who are Hep C
infected can be asymptomatic up to 20 to 30 years. Often by the
time the disease is even diagnosed, the disease has already
progressed to cirrhosis, liver cancer, end-stage liver disease,
or the need for a liver transplant. In those cases, if it had
been caught earlier, there may have been a chance to slow the
progression of the disease with behavior changes, such as
limiting alcohol consumption.
Currently there is no vaccine for hepatitis C. Often
individuals who were administered the hepatitis A and/or the
hepatitis B vaccine believe they are protected against
hepatitis C. This is not the case and these misperceptions show
that we need a better public education campaign about the
disease. Because the virus consistently mutates, there are six
genotypes and over 80 subtypes, manufacturing a vaccine for
hepatitis C is problematic.
Typically the treatment regimen is 6 to 12 months of
injections and oral medications. While treatment has advanced
over the last 10 years, more needs to be done. In about 50
percent of the patients, current treatment does not eliminate
the disease. Also, treatment for Hep C can cause significant
physical and mental side effects, which means the patient
receiving treatment may require additional support from medical
providers and patient support groups to optimize their
treatment outcome.
As mentioned, first responders face an increased risk of
exposure to the disease. Hep C has not only infected but also
has affected a number of first responders within the fire
service and law enforcement arenas. Fairfax County Fire and
Rescue currently has 10 fire fighters infected with the virus
while the city of Philadelphia Fire Department has over 200
fire service personnel stricken by this disease. On a personal
note, I have a younger sibling infected with this virus.
The time to educate, prevent, and screen the at-risk
population is now. Medical experts with knowledge about this
virus continue to echo the urgent need to screen at-risk
populations such as first responders and individuals who had
blood transfusions prior to 1992. Therefore, I urge all
congressional leaders to embrace, promote, and fund the
Hepatitis C Epidemic Control and Prevention Act not only for
first responders but for the American people as well.
Thank you for your time and consideration, and I'd be happy
to answer any and all questions.
[The prepared statement of Mr. Niemiec follows:]
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Chairman Tom Davis. Thank you very much.
Erika, thanks for being here with us. You're a cleanup
hitter here.
Ms. Stein. Thank you. First of all, I would like to thank
you, Congressman Davis, for everything you have done for us
and, Congressman Towns, for everything that you also have done
for us. Thank you.
I was 5 years old when my father was first diagnosed with
hepatitis C. At the time I really didn't understand what this
meant but I could tell that my mother seemed to be very
concerned and I sensed that something was gravely wrong. By the
time I was in fourth grade my father's physician started him on
a course of interferon in hopes of ridding him of the virus. My
dad had to give himself painful injections of the drug several
times a day and the drug caused him to become seriously ill. I
can remember vividly my dad lying on the couch with a fever of
102 and shivering as if he had a bad case of the flu.
During the time my dad was on interferon he became
depressed and seemed like a completely different person to me.
The smallest event could cause my dad to literally go
ballistic, almost like he had changed into the Incredible Hulk.
Our family experienced a great deal of stress and turmoil
throughout the interferon treatment and we were all thankful to
reach its end.
Although he went through nearly 6 months of sheer torture,
the interferon treatment had no effect on his hepatitis C
virus. Needless to say, we were all heart broken at the failure
of the treatment.
Several years later my dad became a patient of the Halt C
study and was started on a course of Pegylated interferon with
Ribavirin at the National Institutes of Health. Before
beginning the treatment, he was given a liver biopsy and they
discovered he had cirrhosis of the liver. He finished the less
painful course of the interferon treatment only to find out
once again that it had no effect on the virus. My dad felt as
if he had failed the treatment, but in truth the treatment
failed him.
In the fall of 2003, I was in my advanced marketing class
and we were deciding what we should focus on as a public
relations project for the school year. I introduced the idea of
doing a project on hepatitis C because it was real life for me
and our Robinson DECA chapter has always dealt with serious
issues that impact the lives of people who are greatly loved.
We discovered that a bill had been introduced in May 2003 that
would allot $90 million for research and education on the
hepatitis C virus.
As you know, Congressman Davis, our DECA chapter takes on
tough issues. We've worked on the Ricky Ray Hemophilia Relief
Fund Act, the Good Samaritan law which protects users of
automative defibrillators, and most recently the Dirty Diamond
Act. I learned that Senator Kay Bailey Hutchison had introduced
bill S. 1143; so I immediately contacted her office to see what
we could do to help. I was then put into contact with Sharon
Phillips, president of the Hepatitis C Advocacy Network based
in Texas, and she was instantly by our side. She and Lorren
Sandt of the Hepatitis C Caring Ambassadors Program flew to
Virginia and came to educate our advanced marketing class.
After Lorren and Sharon's powerful visit, where we learned that
4 million Americans were infected with hepatitis C and 10,000
Americans die each year of the virus, our chapter unanimously
decided that hepatitis C would be our public relations project.
Since October 2003, nearly 500 marketing students from
Robinson Secondary School have been working on Capitol Hill,
visiting congressional offices and persuading health
legislative assistants to encourage their members to co-sign
the Wilson-Towns Hepatitis C Epidemic Control and Prevention
Act, H.R. 3539. We have letters, phone calls, and e-mails of
encouragement from hundreds of hepatitis C patients across the
country.
I have a story to tell you concerning some of the
frustrations that come along with explaining hepatitis C to the
public. A year ago this month, 80 Robinson marketing students
went to New York City for our annual marketing field study. We
planned a side trip at 5 a.m. to visit Rockefeller Center and
be a part of the studio audience of the Today Show. Of course
being good marketing students, we couldn't miss the opportunity
to promote our five fruits and vegetables a day campaign, our
child safety civic consciousness project, and of course the
hepatitis C public relations campaign. Each student was manned
with a poster, except only five posters out of the 80 were
allowed into the Today Show fenced-in area. We were told that
``the Today Show has a family audience and the sexually
oriented hepatitis C thing would not be appropriate for the
audience.'' Security literally threw away our posters because
they thought hepatitis C is a sexually transmitted, dirty
disease.
Chairman Davis, when we began this project a year ago, no
one wanted to talk about hepatitis C. Even a congressional aide
told one of our students that the number of recorded deaths
from his State who are infected with hepatitis C was not enough
to pass the bill. Just one death is too many. The American
people have the right to know about this silent epidemic. Our
government needs to be proactive so we are not caught off guard
like we were with the HIV/AIDS virus in the 1980's.
In this audience today are representatives from the
hemophiliac community who know all too well about viruses that
are spread through our blood supply. Our DECA chapter spent 7
years working on the Ricky Ray bill with hemophiliacs like
Ellis Sulser and Dana Kuhn, who are currently co-infected with
hepatitis C and HIV. Will our generation have a chance to
survive hepatitis C? The answer is yes, Chairman Davis, if we
can stimulate research and education during the 109th session
of Congress.
Chairman Davis, as I close my speech I would like to say I
know you're here representing your constituents and we believe
you care about Americans like my father, Gene Stein. If we
don't provide some funding for research and education for
hepatitis C, it will impact each and every one of our lives.
Thank you.
[The prepared statement of Ms. Stein follows:]
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Chairman Tom Davis. Erika, thank you very much. I'm going
to start with Ms. Norton.
Ms. Norton. Thank you very much, Mr. Chairman. I think
probably this question is best offered to Dr. Rudman. I'm
trying to find evidence of some Federal involvement
commensurate with this disease. Your clinic--is it a clinic--
has an annual budget of $60,000 to $70,000 a year and you have
one full-time employee, etc. How much of that is Federal
funding?
Dr. Rudman. We have no Federal funding. We have no State
funding. The only funding that we have on a governmental level
is local from our Board of County Commissioners.
Ms. Norton. How is that, no Federal funding and no State?
Have you tried to get funding from either of these two
entities?
Dr. Rudman. Yes. Actually, our little clinic got together
with RJO and our STD clinic and our sexually transmitted
disease clinic and our hospital and our mental health programs
and our emergency room and our in-patient psychiatric ward and
Johns Hopkins University's top scientists and we came up with a
grant proposal for a $447,000 viral integration project. And it
turns out that we were actually awarded a $447,000 grant, but
then the funding for that project was cut.
Ms. Norton. Grant from whom?
Dr. Rudman. CDC.
Ms. Norton. When was that?
Dr. Rudman. Earlier this year.
Ms. Norton. The entire grant?
Dr. Rudman. It was a $3.5 million grant and they advertised
it for seven programs. We were one of the seven programs that
was approved. Then what happened, the funding was cut in half
and we were cut in the final cuts.
Ms. Norton. Was this for treatment, for surveillance?
Dr. Rudman. For prevention of hepatitis A and B in at risk
populations and hepatitis C. We were also screening for HIV,
but we would have been probably the only program that offered
treatment for hepatitis C. So that made us kind of special.
Ms. Norton. Do any of you know of any programs in Maryland
and Virginia? I know of none in the District of Columbia,
private or public, which are geared toward this population who
may get or who have hepatitis C?
Dr. Rudman. That's the point I've tried to make.
Ms. Norton. Are you the only program in Maryland?
Dr. Rudman. I'm afraid so. And that is a very sad thing.
Ms. Norton. Any program that you know of in Virginia? Mr.
Chairman, I was just trying to find traces of public health
involvement in what turns out to be a public health menace that
you have uncovered with this hearing. We have heard today that
60 percent of the HIV--60 percent of those with hepatitis C are
HIV drug users. We have heard testimony that many of them are
in prison. And we have heard testimony that the outreach
consists of things like going on-line and posters. I'm afraid
that the problem here is not the disease but perhaps who gets
the disease. This is exactly the problem with HIV/AIDS,
precisely the problem with HIV/AIDS. Until a little boy, a
little white boy and a wonderful poster child got HIV/AIDS, we
didn't wake America up to what now everybody embraces, that
whoever has the disease deserves our help. And if you don't
believe that, do you understand that you are not going to
quarantine them from society, and we learned that the hard way
as AIDS got into our blood supply. And now, of course, nobody
identifies AIDS with gay people. It's all across the aboard.
And that's exactly what's going to happen here. It's not going
to be identified with people who have been in jail or people
who are drug users. And I don't think we should have to wait
for a poster child to deal with the disease.
We have zero funding in this tri-State area on the part of
public health funding. I think what we are dealing with here,
Mr. Chairman, is a second-class disease. And I say so because I
was shocked until your staff told me why it could possibly be
that you had to have HIV/AIDS in order to get treated for
hepatitis C. It is counterintuitive, not true, she said, but
it's probably because the funding stream is available only for
HIV, and nobody has put a red cent into separately funding
hepatitis C. We have to do something about it. I'm pleased that
we can get some money from someplace.
So, Mr. Chairman, I can't thank you enough for your
leadership. You have awakened my consciousness by having this
hearing. I hope what you have uncovered in this hearing, we
will resolve to do for hepatitis C what the country has done
for HIV/AIDS.
Chairman Tom Davis. I thank you very much. I think the
people before us today have done more than we have. They have
brought it--I think keyed it up for us in terms of how we can
follow through, what legislation we can pass and what we can do
in terms of awareness. Mr. Towns has been a leader and has been
the head of the pack, and you are recognized for questions.
Mr. Towns. Thank you very much, Mr. Chairman. Thank you for
your kind words.
Dr. Rudman, the panel before you said that every State had
a coordinator except I think South Dakota and Kentucky. They
didn't say Maryland didn't have one.
Dr. Rudman. Well, that may be because he didn't know
Maryland--Maryland did have one, but she was fired, I think for
doing a good job. You see, not every State wants a hepatitis C
coordinator, because that's going to make people want to spend
State dollars to take care of disease in local communities and
people who run budgets say, we will have to take money away
from other projects or we will have to raise taxes. So we don't
want people to know about this disease. And that's what we're
running into. It's almost as if it's a secret they don't want
to get out.
And so our Department of Health does not have one person
working, one person in the entire State Health Department
working on hepatitis C. And there is some discouragement, I
think, in talking about it, because they'll say well, we can't
do anything about this anyway, we don't have any money. So it's
a nice thing to have good projects. And the State plans--I have
looked at State plans all over the country, which is what I do
for the State of Maryland. Having a plan doesn't mean anything
unless you have the funds to implement them. And that's the
problem. We have a plan in Maryland and we have 39 action
points on it, and we have implemented 6 of them, and those 6 we
would have had to implement for other reasons anyway. So we
have actually implemented zero hepatitis C action plans. And I
think other States are having the same problem.
You know, we need clear guidelines that are ethical and
legally defensible and scientifically sound, but we also need
funds to implement them, and the States are strapped.
Mr. Towns. Thank you very much, Dr. Rudman. Let me say, I
really appreciate the testimony of all of you. I really do, but
I just want to single Erika out, because you know, we feel
about--and people talk about young people not doing anything
positive. But Erika, I want you to know you touched me, the
fact that you are involved in this issue and the fashion that
you are involved in it. I wish the media was fair. Tonight you
would be the leading thing on every news station throughout the
United States of America because of what you are doing in such
a positive way. I salute you and I thank you for your support
of our legislation. I appreciate that as well. So continue to
do so. And eventually, I think that if enough people hear us
that somebody is going to get the message. I think that my son
said to me and I think it's appropriate to comment on here, he
said, sometimes it takes some people 2\1/2\ hours to watch 60
Minutes. That means they can't watch it. It takes them a lot
longer. It takes our country a lot longer to understand where
we need to go and what we need to be about.
I thank you all for coming here today and say to you, do
you have any suggestions or recommendations for us, the Members
of Congress, that we might be able to pursue? I would just like
to spend my last few seconds hearing from you on that issue.
Ms. Stein. I would really say that encouraging other
Members of Congress to co-sign on the bill, and even on the
Senate side, to get them to sign onto the bill. As you can see,
it's vital that we have the funding to do the things that we
need to do. And I think the biggest problem here is the
American public isn't aware of this. Something needs to be done
about this. I don't know what you have to do, but I don't think
it's going to be effective by doing posters and brochures.
Something more needs to be done. And I don't think it should be
necessary that we need a poster child for it to go along with
the disease. It shouldn't be that way. When you see that an
average American is being diagnosed with this--my father has no
idea how he contracted it. He never used drugs, and the only
reason he found out he had it is because he was getting a new
life insurance policy. People need to be aware of it. It's not
fair to the American public that they don't know what's going
on. People need to know what it is and how you can get it.
Mr. Niemiec. I didn't hear anyone testify that about 40
percent of the HIV infected individuals are co-infected with
hepatitis C, about 40 percent. Within our arena of emergency
care, in that very chaotic, unsterile, uncontrolled environment
where a fire fighter, EMT, EMS person sustains a dirty needle
stick, the current stats out there are that individual has
anywhere from a zero to 7 percent risk of now contracting
hepatitis C, and bear in mind that currently there is no post-
exposure prophylaxis for HCV. If I have a dirty needle stick,
there are medications out there called the HIV cocktail. And as
long as I get the cocktail on board within a certain amount of
time, it is not 100 percent efficacious but it's going to
reduce my chances of contracting HIV. I have seen nothing as it
relates to a fire fighter, or EMS personnel sustaining a dirty
needle stick. There are no recommendations from CDC. If I have
a dirty needle stick and if I reside in the State that is
fortunate to have implied consent; in other words, I have
access to that source patient's blood, I may not know whether
or not that patient is infected with hepatitis C. And if I do
find out that the individual is serial positive for hep C,
there is nothing to do about it but sit and wait. So a lot
needs to be done.
Dr. Rudman. I think this goes to the educational problems.
Most doctors don't know this, but if you have acute hepatitis
C, that is new onset hepatitis C, you could treat it with 6
months of interferon alone and current studies indicate that up
to 97 percent of the cases will be cured. This comes from
Stephen Mann's work out in Germany where 43 out of 44 patients
were cured, and we are presently doing that with our acute
cases. With the needle stick injury, that may be one of the
only situations where you are going to identify an acute
hepatitis C case. So if you watch carefully and signs of
hepatitis occur and they don't resolve by themselves, then
there should be a post-exposure treatment program in place.
Ms. Jesse. If I could just urge you to get behind us
passionate advocates, try to get the public aware of this
disease to make them aware that it is everybody's disease that
can affect you and your friends and people like me and try to
break the stigma. And another thing that I constantly work with
in my organization is to try to make people aware that there
are possibly 5 million people infected in the United States and
more than half of them are aware of this. And so help us get
risk factors distributed so people can start self-identifying,
because if you are infected, you need to press on with this. So
do what you can to help us with education and help us get the
funding to move on with this very important work.
Chairman Tom Davis. Let me ask just a couple of questions.
If you don't stop it, though, and it keeps spreading, it
becomes much more difficult further down the road. Erika, when
you discuss hepatitis C with the average person, what's the
reaction you get?
Ms. Stein. A lot of them don't know what it is. When we
introduced it to our class, kids had said they had their
vaccine for it. There is no vaccine for it. And it is very
common you come across people who have no idea what it is or
they can't decipher between hepatitis A, B and C and they have
no idea how serious it is and how easily it can be contracted.
Chairman Tom Davis. And you would be the last person to
stand up here and make this the Erika Stein Show. You have a
team behind, you. Your classmates at Robinson have been so
active in this. And they have been all over Capitol Hill and
everything else, and it makes a difference. Legislation moves
very slowly sometimes. I have been working on some bills since
I got here 10 years ago, but we don't give up. I think this
next session we have a shot of doing some. But time runs out on
this one, because we hear more people getting infected.
Dr. Rudman, do you feel people who come to you that if you
can get ahold of them and have the resources, that you can get
a pretty high cure rate out of it?
Dr. Rudman. That is interesting and perhaps sad because the
people I see are really sick. And when you look at some of the
clean studies that are done, 16 or 13 percent of the people
have severe liver disease when they are entered into random
trials. I'm running 48 percent. So our people are a lot sicker,
and yet our cure rates, even with all of that fibrosis, are as
high as what they get in those clean studies. So if you have a
team that motivates patients and cares about them, even these
tough patients, you can get them cured. And we are able, thanks
to Sharon, to get free drugs for these people. But you have to
have all the other support available to give them the drugs.
And that's what we were able to do in our community.
Chairman Tom Davis. We ought to let more people know about
this and replicate it.
Dr. Rudman. We designed it to be a model. That is one of
the reasons we are here, to get the word out that this can be
treated at the local level and communities. And we certainly do
need more Federal support and funding.
Chairman Tom Davis. NIH has stayed here and I know they are
interested in responding. They want to help. Our job is to make
sure they have some resources along the way.
Captain Niemiec, you mentioned that 10 people in Fairfax
County Fire and Rescue have hepatitis C and other departments
across the country have similar numbers. Is this on the rise?
Mr. Niemiec. It is unfortunate, chairman, that law
enforcement and fire service arenas are not doing any testing,
aren't doing anything. A lot of that is because of education,
awareness, funding, but moreover, if that fire fighter, if that
police officer is now hepatitis C infected, who takes care of
him or her? Whose problem? This is one of the things I have
heard echoed over and over and over again. We don't want to
screen, we don't want to test, because if that fire fighter or
that police officer comes up hep C positive, whose problem does
he or she become?
Chairman Tom Davis. Do you think that is because this is
job related for the most part?
Mr. Niemiec. That's correct.
Chairman Tom Davis. You may want to run down to the
legislature, like you do with heart and lung, to make sure it
is taken care of.
Mr. Niemiec. We are very unique. Latter part of 1999
through 2000, we did a comprehensive screening process with
1,200-plus of our fire fighters. And of those fire fighters, we
had 10 who came up hepatitis C positive. Every year we are
doing our work required under OSHA, blood-borne pathogen
training. It is disquieting and most chilling that a lot of
departments out there, a lot of the first responders, are not
receiving this training, nor are they getting any type of
screening. And we know that they are at risk every single day
he or she puts on that uniform and goes out to the streets.
Chairman Tom Davis. You give me a lot of ideas just hearing
about the seriousness of this. And as we start monitoring this
nationally, this has been fairly recently monitored, and we can
check the rise, but hopefully we can take some actions that can
curb that.
I thank all of you for being here. You add a lot. This has
been televised today on C-SPAN. But more importantly, our
committee will followup with the appropriate reports. We have
to work with other committees of jurisdiction on funding and
the like. I know Mr. Towns isn't discouraged. He is going to
keep trying and we will be looking for new ways and hopefully
we made a small difference here today. Thank you for taking
time to be here, and for all of the Robinson kids. This is one
of series of different causes that they have adopted through
time, and they weren't here for Ricky Ray and several of the
other issues that took several years, but I appreciate their
can-do spirit and it's contagious. So we appreciate it, and
thank you for your continued advocacy. Hearing is adjourned.
[Whereupon, at 4:20 p.m., the committee was adjourned.]
[The prepared statements of Hon. Mark E. Souder, Hon.
Elijah E. Cummings, Hon. Ileana Ros-Lehtinen, Hon. Heather
Wilson, and Hon. Sheila Jackson Lee, and additional information
submitted for the hearing record follow:]
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